Medical Device Cybersecurity Risks & Best Practices
Navigating the Nuanced Cyber Regulatory Waters

Tuesday, Dec. 18, 2018 · 1:30 p.m. - 3:00 p.m. EST

Smart medical devices have underlying cybersecurity and privacy risks. They are also top targets from a host of global attackers from nation states to sophisticated criminal gangs. The health sector — including medical device manufacturers as well as pharmaceutical and biotech companies — faces uncharted regulatory and liability risks.

FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies.

Over the course of 90 fast-paced minutes, Ms. Krayem will move from the Cybersecurity Executive Order 13800 to HIPAA, Homeland Security and more:

  • Cybersecurity-triggered changes in the interpretation of HIPAA, and enforcement by the HHS Office of Civil Rights, as they affect quality and regulatory matters
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms
  • Homeland security: How DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities, and regulation of companies
  • The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”
  • New international privacy and cybersecurity laws impacting the health sector
  • And much more

With U.S. agencies — FDA, HHS, DHS — all at work on new sector risk bulletins and re-evaluation of current rules such as HIPAA, and global regulators equally involved, this is a pressing matter. Address it now, by committing an hour and a half of your time to this timely learning session. Register today.

Who Will Benefit

Cybersecurity is a multi-discipline activity, so team participation in the presentation is important. Team members include:

  • Design Engineers
  • Software Engineers
  • Software Validation Specialists
  • Risk Managers
  • Complaint Managers
  • Complaint Analysts
  • Regulatory Affairs Managers
  • Submission Specialists

Webinar plus Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript
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$487

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24/7 Encore Presentation
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$287

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Audio Recording/Transcript
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$287

add to cart

 

 

 

Meet Your Presenter

Norma Krayem

Sr. Policy Advisor and Co-Chair, Cybersecurity and Privacy Team
Holland & Knight

Norma is a well-known cybersecurity expert in a host of sectors including health and understands the global regulatory structure for medical devices. She will talk about the current and emerging regulatory environment and discuss the nexus of cyber risk to the Internet of Things (IoT) as well which will impact the medical device industry. She is regularly sought out by the media, policy and elected officials around the world on cyber risk.

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